Karan Singh, Managing Director at ACG, comments: “Exposing considerable weaknesses in supply chains across the globe, the pandemic has compelled the pharma and healthcare sectors to revisit their strategy and shift away from a just-in-time approach to a just-in-case one.”
“In 2022 and beyond, we will see a rise in new delivery models built on a resilient value chain by leveraging the benefits of digitalisation. Through smart, connected and intelligent systems based on Industry 4.0 technologies, India stands to emerge as a global manufacturing hub, supporting the pharma industry to produce safe, quality and affordable drugs,” he adds.
Kelly Doering, Senior Director, Industry Marketing, Pharma, at AspenTech, notes that the speed at which pharmaceutical companies developed and brought new COVID vaccines to market in 2021 was widely celebrated. “Throughout 2022, manufacturers will focus on developing a more efficient production cycle to expedite the time-to-market for all medicines."
"The objective will be to ensure quality, automate time-consuming processes, reduce risks, remove unplanned downtime and prevent bottlenecks. To support this vision, pharmaceutical companies are increasingly turning to a digital workflow powered by industrial artificial intelligence (AI) is areas such as planning, scheduling, production and asset management.”
“The use of real-world data will have a greater impact on decision making in pharma,” she continues. “Pharma companies have been seeing the benefits of aggregating and analysing real-world data from a variety of sources, including gaining insights that will help them to improve the development and commercialisation of safe and efficacious drugs to the marketplace."
Bringing data together with real-world evidence that informs the next therapeutic, the next set of criteria for a clinical study population or to better apply learnings from post-market surveillance data requires powerful digital and analytics tools to enable this. We expect these tools to be even more widely used in the industry in 2022.”
Rik Van Mol, Vice President, R&D Strategy, Europe, at Veeva, agrees: “Drug development will increasingly rely on a single, consistent source of data,” he says. As R&D teams work to reduce point solutions, many are realising the importance of data quality. On the clinical side, for example, patient data must be aggregated and cleaned if data from new sources — such as wearables — is to connect to clinical and clinical operations data. Companies that cannot do this will find it difficult to learn from past events to improve operations.”
“That’s why, in 2022, we expect to see more companies adopt data management tools that will automate and speed up this work by ingesting, aggregating and cleaning data so that it’s easier to analyse, report on and share.”
“GSK and Novartis are among the companies focusing on data quality and moving toward real-time interactive dashboards (using a platform approach that simplifies data exchange). Instead of merely storing data in a data lake and then analysing it, this approach deals with the disparity of data and their sources, whether input manually or sent from sensors. The result will be a single source of data that will improve cross-functional collaboration by allowing information to flow easily to different functions within drug development.”
Quality control is alive and well
Automation and analytics are driving more innovation by delivering quality throughout the pharmaceutical ecosystem. “For example,” offers Kelly, “using quality by design (QbD) principles and process analytics, manufacturers can monitor critical quality and performance to ensure final product quality within a compliant environment."
Advanced process analytical technology (PAT) is key to this. PAT is the implementation of at-line and inline advanced measurement systems to provide full visibility of critical process parameters and their effects on the critical quality attributes. PAT is a powerful enabler for QbD, which helps ensure product quality through judicious process design, monitoring and control. Such are the benefits that we’d expect to hear much more about both PAT and QbD during 2022.”
“In 2022, automating manual processes and finding new ways to process information will be crucial to improving patient safety and maintaining compliance,” adds Rik: “So will simplifying data management systems, their validation and ongoing maintenance. Within the past year, more than 50 life sciences companies, from small innovators to large enterprises, have modernised pharmacovigilance data management to streamline safety operations.”
“R&D may have been one of the last areas to modernise and transform its operations,” he continues, “but the use of new business approaches and technology have had a major impact on operations within the clinical and regulatory environment. Pharmacovigilance is now catching up, as more companies re-examine the way they handle case intake and processing, in parallel with their document management needs."
"Safety departments are also taking a more proactive approach earlier in drug development and investigating more advanced technologies for signal detection, analysis and management.”
“As the technology modernisation trend continues next year, safety departments will focus on the opportunity to manage their end-to-end pharmacovigilance processes and information more holistically, in a more efficient and compliant manner.”
Manufacturers will focus more on transforming continuous processes
With much discussion about the benefits of moving from batch to continuous manufacturing for improved quality, throughput and yield, it’s important that manufacturers put the right technologies in place to optimise the latter approach.
“Process performance monitoring becomes a network of online models supervising desired operational indicators and key performance metrics,” advises Kelly. “The models will provide automated 24x7 insights and propose adjustments for continuous processes. At the same time, control solutions are emerging that can predict batch results and anticipate deviations from target and automate corrective action, enabling more consistent efficient operations.”
“Furthermore, electronic batch record (EBR) systems will drive benefits throughout the pharmaceutical sector during 2022. They contain the logic and rules that enforce the manufacturing workflow. They improve data integrity, minimise error, enable efficient batch review by exception, reduce paper and manual entries and capture contextualised data to power industrial AI and advanced analytics. Audit trails, electronic signatures and documentation needed for compliance are part of the feature set.”
The consumer perspective
John Carey, Head of Sales at ACG Engineering, predicts that 2022 will see another year of consumer trends driving changes across the pharmaceutical and nutraceutical supply chain. "Manufacturers will need to balance fast moving consumer trends with long-term infrastructure updates — which is no easy feat."
"Flexibility will be a key driver for these companies in 2022. To incorporate more flexibility, manufacturers will likely look to improved automation, data analytics, machine learning and the IIoT. Smart factories can use real-time data analytics and machine learning to reduce costs, improve quality, and reduce capacity constraints."
"Developments in predictive analytics have made it possible for manufacturers to draw on vast pools of data, including information on resource consumption, machine performance and storage conditions on factory floors to troubleshoot problems, optimise processes and boost productivity."
“Another prominent trend for 2022 is the move towards creating larger batch sizes. Larger batches mean companies can be more efficient by reducing costs associated with quality control and validation. However, the common practice of combining smaller batches together can bring its own challenges as consumers increasingly opt for more personalised treatments. Therefore, equipment that offers more bespoke options and is capable of handling a wide range of batch sizes is becoming more popular.”
Offering the final word, Rik suggest that patient and site centricity will drive the next phase of clinical trials. “During the pandemic, the industry accelerated the adoption of decentralised trial capabilities to bring more trial elements directly to the patient. However, predictions that pharma would adopt a fully virtual model in which sites become less relevant have already been proven wrong.”
“Instead, the industry is moving towards a hybrid model of trial execution with some decentralised elements. Sites (and the investigator) will continue to play a vital role as touchpoints for patient engagement and retention. As more clinical data is captured electronically, we’ll see faster trials that are better managed and speed the delivery of new therapies.”
“In addition to more effective data management, greater patient and site centricity will drive further changes in studies. Some of the decentralised clinical trials that ran in 2020 and 2021 weighed patients down with numerous digital applications, whereas research sites felt burdened with a multitude of point solutions that made it more difficult to manage trials."
"Now, as they work to reduce the technology burden on patients, more sponsors will minimise the digital applications and portals that they require sites to use. This will enable sites to spend less time on administrative functions and more on patient safety and care.”